High-flow Nasal Cannula OxygenNCT03384394
Evaluating High-flow Nasal Cannula Oxygen Therapy Through LUS During Weaning
A study testing high-flow nasal cannula oxygen and Conventional oxygen therapy in people with High-flow Nasal Cannula Oxygen, run by lu xiao.
Trial summary
Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-flow Nasal Cannula Oxygen
- What is being tested?
- high-flow nasal cannula oxygen and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients above 18, mechanically ventilated on tracheal intubation for more than 48 hours.
Who cannot join
- Patients with chronic obstructive pulmonary disease (COPD) with moderate to severe (3 and 4) stage defined by a forced expiratory volume in one second (FEV) <50% of theoretical value
- Patients with previous chronic respiratory disease
- Paraplegia with level> T8,
- Severe ICU-acquired neuromyopathy
- Patients with tracheostomy for any reason.
About this study
Official title: Evaluating High-flow Nasal Cannula Oxygen Therapy Through Lung Ultrasound Score
Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS). Investigators have recently demonstrated in a prospective two-center study of 100 patients that the intensity of the lung aeration loss occurring during the weaning trial, was predictive of the development of postextubation respiratory distress within 48 hours following extubation. A LUS ≥ 14 could identify patients at high risk of developing postextubation respiratory distress. A second study that investigators have just completed in 80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group.
The establishment of a targeted therapeutic strategy proposed in a group of high-risk patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the incidence of extubation failure and associated morbidity and mortality.
- Conditions
- High-flow Nasal Cannula Oxygen
- Being tested
- high-flow nasal cannula oxygen, Conventional oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow nasal cannula oxygenDevice
high-flow nasal cannula oxygen
Conventional oxygen therapyDevice
oxygen by a standard nasal cannula or nonrebreather mask
| Study group | Role | What they receive |
|---|---|---|
| Conventional oxygen therapy | Placebo comparator | oxygen by a standard nasal cannula or nonrebreather mask Receives: Device: Conventional oxygen therapy |
| High-flow Nasal Cannula Oxygen Therapy | Active comparator | High-flow Nasal Cannula Oxygen Therapy Receives: Device: high-flow nasal cannula oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
Measured: 48 hours
Secondary outcomes (1)
Number of ventilation-free days in ICU following the planned extubation after randomization. - Length of stay in ICU and in-hospital after randomization. - Mortality in ICU and at three months.
Number of ventilation-free days and mortality in ICU and at three months.
Measured: treatment in ICU and at three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Mar 2018 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-flow Nasal Cannula OxygenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- lu xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, lu xiao, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384394
- Sponsor's protocol ID
- 214856056
- Status last verified
- Feb 2018
- First submitted
- 1 May 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating High-flow Nasal Cannula Oxygen Therapy Through Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT03384394
- Acronym / sponsor ID
- 214856056
- Conditions
- High-flow Nasal Cannula Oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- lu xiaoUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS). Investigators have recently demonstrated in a prospective two-center study of 100 patients that the intensity of the lung aeration loss occurring during the weaning trial, was predictive of the development of postextubation respiratory distress within 48 hours following extubation. A LUS ≥ 14 could identify patients at high risk of developing postextubation respiratory distress. A second study that investigators have just completed in 80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group.
The establishment of a targeted therapeutic strategy proposed in a group of high-risk patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the incidence of extubation failure and associated morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional oxygen therapy | Placebo comparator | Device: Conventional oxygen therapyoxygen by a standard nasal cannula or nonrebreather mask |
| High-flow Nasal Cannula Oxygen Therapy | Active comparator | Device: high-flow nasal cannula oxygenHigh-flow Nasal Cannula Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients above 18, mechanically ventilated on tracheal intubation for more than 48 hours.
Key exclusion criteria (5 listed)
- Patients with chronic obstructive pulmonary disease (COPD) with moderate to severe (3 and 4) stage defined by a forced expiratory volume in one second (FEV) <50% of theoretical value
- Patients with previous chronic respiratory disease
- Paraplegia with level> T8,
- Severe ICU-acquired neuromyopathy
- Patients with tracheostomy for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-flow nasal cannula oxygenhigh-flow nasal cannula oxygen | Device | High-flow Nasal Cannula Oxygen Therapy |
| Conventional oxygen therapyoxygen by a standard nasal cannula or nonrebreather mask | Device | Conventional oxygen therapy |
Primary outcome
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
Time frame: 48 hours
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients.
1 secondary outcome
Number of ventilation-free days in ICU following the planned extubation after randomization. - Length of stay in ICU and in-hospital after randomization. - Mortality in ICU and at three months.
Time frame: treatment in ICU and at three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow nasal cannula oxygen and Conventional oxygen therapy in people with High-flow Nasal Cannula Oxygen, run by lu xiao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.